Evaluating Q-Collar Effects on Brain Blood Flow Control During Exercise
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorSpaulding Rehabilitation Hospital
About this trial
The goal of this clinical trial is to learn how the FDA-cleared Q-Collar device affects brain blood flow regulation during rest and exercise in healthy adults. The main questions this study aims to answer are:
1. How does the Q-Collar affect brain blood flow when there are quick changes in blood pressure, like when standing up quickly, or when breathing against resistance? 2. How does the Q-Collar affect brain blood flow during exercise?
Researchers will compare sessions where participants wear the Q-Collar to sessions where they do not wear the device to see if the Q-Collar improves brain blood flow during both rest and exercise.
Participants will:
* Complete two study visits, each 1 to 4 weeks apart. * Perform a series of tasks, including standing tests, breathing tests, and exercise on a stationary bike, while their heart rate, brain blood flow, and other body functions are monitored. * Wear the Q-Collar during one of the sessions and not wear it during the other session. The order of the sessions will be randomly assigned.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
healthy individuals between the ages of 18 to 30 years old
Disqualifiers
History of concussion or other brain injury resulting in loss or alteration in consciousness or other change in cognition within 24 months of study visit
High cardiac risk according to the American College of Sports Medicine (ACSM)11
Ongoing active treatment with a cardioactive drug
Inability to stand from a seated position unassisted
Trial design
Design model
Single group
Treatments tested in this trial
Q30 Q-Collar
DeviceParticipants will complete a series of tests (sit-to-stand, resistive breathing, and graded bike test) while wearing a Q-Collar.
Not wearing Q-Collar
Other interventionParticipants will undergo the same study procedures without wearing the Q-Collar.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cerebrovascular Control with Q-CollarExperimental treatment 1 intervention
Group B: Cerebrovascular Control without Q-CollarPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sit-to-Stand Test: Autoregulatory Slope
The slope of the autoregulatory curve, representing the change in cerebral blood flow in response to rapid shifts in blood pressure during the sit-to-stand transition.
Time frame
2 study visits within a 4 week time frame2
Resistance Breathing Test: Autoregulatory Gain
The autoregulatory gain, which reflects the brain's ability to maintain stable cerebral blood flow during sinusoidal fluctuations in blood pressure induced by resistance breathing.
Time frame
2 study visits within a 4 week time frame3
Graded Bike Test: Change in Cerebral Blood Flow
The change in cerebral blood flow velocity (CBFV) during the graded exercise test, assessed by Transcranial Doppler ultrasonography, indicating how cerebral blood flow responds to increasing physical exertion.
Time frame
2 study visits within a 4 week time frameSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov